A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients

April 8, 2015 updated by: Proteon Therapeutics

A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Clarian Health Partners/Indiana University/Purdue University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Springfield, Massachusetts, United States, 01104
        • Western new England Renal & Transplant Associates
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Sentara Medical Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age of at least 18 years.
  • Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
  • Planned creation of a new AVF.

Exclusion Criteria:

  • Patients for whom this is the only potential site for an AVF.
  • By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch.
  • Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent.
  • Pregnancy, lactation or plans to become pregnant during the course of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: PRT-201
Applied topically to AVF during surgery
Drug: PRT-201
Dose escalation study. Drug/placebo administered at the time of fistula creation
Active Comparator: PRT-201
Drug: PRT-201
Applied topically to AVF during surgery
Drug: PRT-201
Dose escalation study. Drug/placebo administered at the time of fistula creation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein.
Time Frame: 2 & 6 weeks after AVF creation
2 & 6 weeks after AVF creation

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis.
Time Frame: 3, 6, 9, and 12 months
3, 6, 9, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Proteon Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

May 15, 2008

First Submitted That Met QC Criteria

May 16, 2008

First Posted (Estimate)

May 19, 2008

Study Record Updates

Last Update Posted (Estimate)

April 30, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRT-201-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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